FDA recall D-0075-2021

Product

Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count carton (10 x10 unit-dose), Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534, NDC 68382-772-77

Reason for recall

Failed Dissolution Specification

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-10-27

Report date

2020-11-11

Termination date

2022-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pennington, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2021